Early Feasibility Clinical Study to Investigate the Safety and Performance of TransLoc® Electrodes for Temporary Diaphragm Pacing in Patients Undergoing Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participant That Experience Adverse Procedure and/or Device Effects
研究概览
简要总结
Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in the Intensive Care Unit (ICU).
详细描述
This is a prospective, open-label, single-center study to examine the feasibility of the TransLoc DPS electrode placement and removal. Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes) and will be followed until electrode removal up to seven days post-procedure. Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing a surgical procedure with expected admission to the hospital.
- •Patient is undergoing a laparoscopic, open abdominal, or open chest surgical procedure that allows access to the diaphragm.
- •Negative pregnancy test if the patient is a female of child-bearing potential.
- •Patient is at least 18 years of age.
- •Informed consent has been obtained from the patient or designated representative.
排除标准
- •Patient has an implanted cardiac defibrillator.
- •Patient is pregnant or breastfeeding.
- •The patient is involved in another clinical study that could influence the safety or outcome measures of this study.
研究组 & 干预措施
TransLoc electrode
Electrode placement
干预措施: TransLoc electrode (Device)
结局指标
主要结局
Number of Participant That Experience Adverse Procedure and/or Device Effects
时间窗: Implantation through hospital discharge or Day 7, whichever comes first.
All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
时间窗: Postoperatively on Day 1
Successful placement of two TransLoc electrodes in each hemi-diaphragm of the study participants during the operative procedure. Success was the ability to perform stimulation postoperatively using the implanted electrodes to effectively stimulate the patients for ventilation as evidenced by the ability to successfully achieve the predicted tidal volume.
Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
时间窗: Postop Day 1 through hospital discharge or 7 days, whichever comes first
Electrode stability was determined by using the electrodes to record tracings of the diaphragm EMG daily for at least a 10 minute period. The tracings were reviewed to determine diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any. The recordings also confirmed electrode stability (non-displacement and electrical integrity) during the period of temporary implantation.
Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
时间窗: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Number of study participants in which TransLoc electrodes were removed intact without device fragmentation or the occurrence of device or procedure related adverse events. Removal was performed by the healthcare provider by pulling electrodes from the percutaneous entry point. This was done in a similar fashion as a temporary cardiac pacing wire with a slow steady pull in a straight non oblique line.
Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
时间窗: Postoperatively Day 1
Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.
Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
时间窗: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.
次要结局
- Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)(Postop Day 1)
- Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.(Postop Day 1 through hospital discharge or Day 7, whichever comes first)
- Comparison of Percentage of Predicted Tidal Volumes Measured.(Postop Day 1)